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U.S. Department of Health and Human Services

Drugs

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FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products

September 25, 2009

The U. S. Food and Drug Administration wants to make consumers aware of a voluntary recall conducted by McNeil Consumer Healthcare of certain lots of oral suspension Children's and Infants' TYLENOL products. This recall was done as a precautionary measure because of potential manufacturing problems. The voluntary recall does not include other Tylenol products.

The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. The company’s analysis of the finished product did not reveal any bacterial contamination.

The full list of recalled product lots can be accessed on the company’s Web site at http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc Exit Disclaimer.

The FDA is working closely with the company to monitor this recall. There are no illnesses reported by patients using this product.

Adverse events and product quality problems can be reported to FDA's MedWatch Adverse Event Reporting program:

  • MedWatch Online
  • by calling 800-FDA-1088
  • by returning the postage-paid FDA form 3500
  • by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
  • by fax 800-FDA-0178